Vital GMP Requirements for Records and Reports

Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. The webinar will discuss basic/key requirements for writing SOPs, recording data, completing forms and other basic documentation requirements for the GMP compliant company. Furthermore, the current industry requirements for recordkeeping will be discussed.

Why You Should Attend:

‘If it’s not written down, then it didn’t happen!’ The basic rules in any Good Manufacturing Practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records. Effective documentation enhances the visibility of the quality assurance system. In light of above facts, it is very important for every company to know about the records and reports related to GMP requirement.

Areas Covered in the Session :

• Good Documentation Practices Do’s and Don’ts
• Defining raw data, records and reports
• Correcting errors and omissions
• Comments and explanations
• Data integrity and traceability
• cGMP requirements for changing and controlling entries into documents
• Establishing protocols and reports
• Evaluating and storing analytical data
• Archiving of records
• Current industry best practices for GDP
• Interactive Q&A Session

Who Should Attend:

• Quality Departments
• Research and Development Departments
• Engineering Departments
• Manufacturing Departments
• Production Departments
• Operations Departments
• Laboratory Personnel (chemists, technicians, supervisors)
• Validation Departments
• Batch Record Reviewers
• Maintenance and Warehousing Personnel

Course Director: PEGGY J BERRY

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).